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IRCT20180129038545N3 IRCT 2026-10-13 Tehran University of Medical Sciences Physical Activity Intervention in Type 2 Diabetes Evaluation of the Effectiveness of Pilot Implementation of Physical Activity Intervention of WHO at the Level of Physical Activity on Adults with Type 2 Diabetes 2026-12-22 anticipated 80 Pending https://irct.ir/trial/78915 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible participants based on inclusion and exclusion criteria, after receiving a comprehensive explanation of the study, providing written informed consent, and having their demographic information and baseline assessment data definitively recorded in the study database, will be irrevocably entered into the randomization process to prevent selection bias during participant enrollment. Participants will be individually allocated to the intervention and control groups in a 1:1 ratio. The simple randomization sequence will be generated before the commencement of participant recruitment by an independent biostatistician who is not involved in the clinical team or patient recruitment process, using the random number generation module of SPSS statistical software, version 26. To minimize selection bias at the allocation stage, sequentially numbered, opaque, sealed, foil-lined envelopes will be used for allocation concealment. Each envelope will be opened strictly in numerical sequence and only after the participant's baseline information has been definitively recorded in the study database. This procedure will ensure that the treating physician has no opportunity to predict or influence the allocation of the next participant. Thus, group allocation will remain concealed until each participant’s enrollment in the study has been finalized, Blinding description: In this double-blinded study, the participants and the data analyzers are blind to the study groups. The participants of both case groups will undergo primary education about physical activity, but only one case group will receive text messages during the six weeks of intervention. The control group will receive no education and text messages. The investigator of the study is not blind to the study groups, but the analyzers are not aware of the study groups. N/A Type 2 diabetes. Intervention 1: Intervention group1: Receiving text messages about physical activity along with primary educational content. At baseline, participants receive oral and written educational content about the importance of physical activity for people with type 2 diabetes. Those who are assigned to this case group will receive text messages as well. The intervention lasts six weeks and the case group receives three text messages each week (total = 18 messages). The content of messages varies and ranges from motivation, information, and encouragement to monitoring oneself. Intervention 2: Control group: The participants of this group will not receive text messages and they will not receive education content about physical activity. Intervention 3: Intervention group 2: Receiving only primary educational content. At baseline, participants receive oral and written educational content about the importance of physical activity for people with type 2 diabetes. This group will not receive text messages. Yes - There is a plan to make this available What will be shared: Information of the outcomes, including physical activity levels and attitudes towards it, will be shared. When: The data will be available starting six months after publication. To whom: People working in academic institutions can apply to receive the data. Conditions: No limitation is set. Where to obtain: Contact the email selk1360@gmail.com How to obtain: Thr data will be available starting 6 months after publication by contacting selk1360@gmail.com for 6 month after obtaining contact information of the researcher. Comments:
public Maryam Selk Ghaffari
No. 7, Jalal Al Ahmad Ave., Sports Medicine Research Center
Tehran Iran (Islamic Republic of) 1411734143 +98 21 8863 0228 selk1360@gmail.com Tehran University of Medical Sciences scientific Maryam Selk Ghaffari
No. 7, Jalal Al Ahmad Ave., Sports Medicine Research Center
Tehran Iran (Islamic Republic of) Tehran +98 913 441 8154 selk1360@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) People aged 18-65 with diagnosed type 2 diabetes Inactive people based on WHO (less than weekly 150 minutes of moderate-intensity activity) Being able to read and write Having access to a mobile phone that receives SMS Informed consent 18 years 65 years Both Being diagnosed with uncontrolled hypertension, heart failure, valvular heart disease, advanced lung disease, stroke, or myocardial infarction in the last 6 months Severe, unplanned weight loss (more than 10%) in the last 6 months Pregnancy Any condition or disease, including orthopedic conditions, preventing from physical activity A positive response to one or more items of the Physical Activity Readiness Questionnaire (PARQ-10) E11.9 Type 2 diabetes mellitus without complications Lifestyle Lifestyle Lifestyle Intervention group1: Receiving text messages about physical activity along with primary educational content. At baseline, participants receive oral and written educational content about the importance of physical activity for people with type 2 diabetes. Those who are assigned to this case group will receive text messages as well. The intervention lasts six weeks and the case group receives three text messages each week (total = 18 messages). The content of messages varies and ranges from motivation, information, and encouragement to monitoring oneself. Control group: The participants of this group will not receive text messages and they will not receive education content about physical activity. Intervention group 2: Receiving only primary educational content. At baseline, participants receive oral and written educational content about the importance of physical activity for people with type 2 diabetes. This group will not receive text messages. Level of physical activity. Timepoint: Before and after the intervention. Method of measurement: Exercise Vital Sign questionnaire. Attitudes toward physical activity. Timepoint: Before and after the intervention. Method of measurement: Attitudes toward physical activity questionnaire. Tehran University of Medical Sciences Approved 2023-10-08 Ethics committee of Tehran University of Medical Sciences 16th Azar St., Enghelab Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)